April 23, 2015
1 min read

FDA grants breakthrough therapy designation to Xalkori for ROS1-positive NSCLC

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

The FDA granted breakthrough therapy designation to crizotinib for the treatment of patients with ROS1-positive non–small cell lung cancer, according to a press release from the drug’s manufacturer.

Crizotinib (Xalkori, Pfizer) — a tyrosine kinase inhibitor — was approved in 2011 for the treatment of patients with NSCLC who harbor ALK mutations.

The FDA based the breakthrough therapy designation on results of a global phase 1 study which evaluated crizotinib in 50 patients with ROS1-positive advanced NSCLC. Results — published in November 2014 in The New England Journal of Medicine —demonstrated anti-tumor activity in patients who received crizotinib.

The safety profiles of crizotinib were similar among patients with ROS1-rearranged and ALK-positive advanced NSCLC, according to the press release.

 “We are excited that the FDA has granted Breakthrough Therapy designation for Xalkori as a potential treatment for patients with ROS1-positive NSCLC,” Mace Rothenberg, MD, chief medical officer for Pfizer Oncology, said in a press release. “Xalkori pioneered precision medicine for ALK-positive metastatic NSCLC, and ROS1 represents a second molecular subgroup of NSCLC in which Xalkori has demonstrated a level of anti-tumor activity that can potentially make a real difference for patients.”